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Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders (TIMBER)

Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders (TIMBER)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00101881
Enrollment
168
Registered
2005-01-19
Start date
2002-11-30
Completion date
2005-01-31
Last updated
2008-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Keywords

Cardiac arrest, Defibrillation, Biphasic defibrillation, Monophasic defibrillation, Ventricular fibrillation

Brief summary

The study compares the effectiveness of two fully approved shock waveforms (monophasic and biphasic shock) commonly used to defibrillate (shock) patients with out-of-hospital cardiac arrest due to a highly lethal rhythm problem (ventricular fibrillation). The purpose of the study (hypothesis) is to determine if one waveform results in improved resuscitation, admission alive to hospital, and discharge alive from hospital compared with the other.

Detailed description

The trial is designed to determine whether two fully-FDA-approved, commercially available transthoracic defibrillation shock waveforms at comparable energies result in improved patient outcome following out-of-hospital cardiac arrest due to ventricular fibrillation. Eligible subjects include all adults with nontraumatic out-of-hospital cardiac arrest due to ventricular fibrillation. Subjects in cardiac arrest will be randomly allocated to receive one of two types of defibrillation shocks (monophasic or biphasic waveform) during their resuscitation, which will in addition include all other standard treatments. The primary endpoint is admission alive to hospital. Secondary endpoints include rhythm after defibrillation shock, return of spontaneous circulation, and hospital discharge rates.

Interventions

DEVICEDefibrillation (biphasic versus monophasic shock)

Administration of monophasic or biphasic waveform defibrillation

Sponsors

Medic One Foundation
CollaboratorOTHER
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult victims of nontraumatic out-of-hospital cardiac arrest due to ventricular fibrillation

Exclusion criteria

* Children * Trauma

Design outcomes

Primary

MeasureTime frame
Admission alive to hospitalWithin hours of intervention

Secondary

MeasureTime frame
Rhythm after defibrillation shockWithin minutes of intervention
Return of spontaneous circulationWithin minutes of intervention
Hospital discharge ratesWithin days of intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026